| CTRI Number |
CTRI/2025/08/093735 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study Comparing Split Dose And Single Dose Spinal Anaesthesia In Infraumbilical Abdominal Surgeries. |
|
Scientific Title of Study
|
A Comparative Study Of Hemodynamic Stability And Anaesthetic Efficacy Of Fractioned And Single Dose Spinal Anaesthesia In Infraumbilical Abdominal Surgeries.A Prospective Randomised Control Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mounisha SV |
| Designation |
Post graduate Student |
| Affiliation |
shri sathya sai medical college and research institute |
| Address |
Department of Anaesthesiology
2nd floor , Hospital block
shri sathya sai medical college and research institute
ammapettai kancheepuram
tamilnadu india
Department of Anaesthesiology
2nd floor , Hospital block
shri sathya sai medical college and research institute
ammapettai kancheepuram
tamilnadu india
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9791288909 |
| Fax |
|
| Email |
svcmounishavinayagam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jagan G |
| Designation |
Assossiate Professor |
| Affiliation |
shri sathya sai medical college and research institute |
| Address |
Department of Anaesthesiology
2nd floor , Hospital block
shri sathya sai medical college and research institute
ammapettai kancheepuram
tamilnadu india
Department of Anesthesiology
2nd floor hospital block
shri sathya sai medical college and research institute
ammapettai kancheepuram
tamilnadu india
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9791288909 |
| Fax |
|
| Email |
drjagangovindasamy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mounisha SV |
| Designation |
Post graduate student |
| Affiliation |
shri sathya sai medical college and research institute |
| Address |
sssmcri women hostel
shri sathya sai medical college and research institute
ammapettai kancheepuram
tamilnadu india
sssmcri women hostel
shri sathya sai medical college and research institute
ammapettai kancheepuram
tamilnadu india
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9791288909 |
| Fax |
|
| Email |
svcmounishavinayagam@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mounisha SV |
| Address |
sssmcri women hostel
shri sathya sai medical college and research institute
ammapettai kancheepuram
tamilnadu india |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mounisha SV |
Shri sathya Sai Medical college and Research Centre |
Department of Anesthesiology
2nd floor , Hospital block shri sathya sai medical college and research institute
ammapettai kancheepuram
tamilnadu india
Kancheepuram
TAMIL NADU |
9791288909
svcmounishavinayagam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA 1 and 2 |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fractionated spinal anaesthesia |
In this patient will receive 2/3rd of same mixture initially with remaining 1/3rd injection after 60 sec |
| Comparator Agent |
Single dose spinal anaesthesia. |
In single dose spinal anaesthesia Entire dose of 0.5 percentage bupivacaine given as single bolus |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.patient assesed under ASA1 and ASA2
2.patient BMI between 20-30
3.patient posted for infraumblical abdominal surgeries |
|
| ExclusionCriteria |
| Details |
1.patient with active infection at the site of spinal anaesthesia
2.patient with a known allergy to any of the spinal anaesthesia
3.patient with coagulation abnormality or bleeding disorder
4.patient who are contraindicated to spinal anaesthesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the hemodynamic stability between two groups in terms of monitoring MAP,heart rate ,spo2 |
first 24hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective double blind randomized controlled trial will evaluate the comparative effects of fractionated and single dose spinal anaesthesia in adult patients undergoing infraumbilical abdominal surgeries. Fractionated spinal anaesthesia, where the intrathecal dose is divided into two parts, is expected to provide better hemodynamic stability and prolonged analgesia compared to conventional single dose technique. The study will include 110 patients aged 18 to 60 years, ASA physical status I and II.results aim to guide safer anaesthesia pratice by reducing complication like hypotension and improving perioperative outcomes |